Trial Outcomes & Findings for The International Diabetes Closed Loop (iDCL) Trial: Clinical Acceptance of the Artificial Pancreas (DCLP3 Extension) (NCT NCT03591354)
NCT ID: NCT03591354
Last Updated: 2022-08-31
Results Overview
The primary exploratory outcome is time in target range 70-180 mg/dL measured by CGM comparing the randomized groups CLC vs PLGS. Results from SAP to CLC group is also included here without the primary intention of comparing to CLC vs PLGS groups.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
164 participants
Primary outcome timeframe
13 weeks
Results posted on
2022-08-31
Participant Flow
Objective 1 (Primary): Participants with 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial) were randomized to either CLC or PLGS with outcomes evaluated during the 3 mo extension. Objective 2: Participants with 6 mos of SAP in the primary trial (DCLP3 Pivotal Trial) were then transitioned to CLC during the 3-mo extension. Objective 3: All participants who completed the initial 3 mos of the extension trial continued use of CLC until the system was commercially available.
Participant milestones
| Measure |
Closed Loop Control (CLC)
Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).
|
Predictive-Low Glucose Suspend (PLGS)
Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).
|
SAP to CLC Group
Participants in this arm were transitioned to CLC (t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM) after the extension began. Participants in this arm had previously been randomized to Sensor-Augmented Pump (SAP) in the primary trial (DCLP3 Pivotal Trial). This arm met Objective 2 of the study and was not compared to the CLC and PLGS groups that were randomized during the extension.
Participants in this arm will continue to use CLC through commercial availability of the device after the completion of the 3 months extension (Objective 3 of the trial).
|
|---|---|---|---|
|
Overall Study
STARTED
|
54
|
55
|
55
|
|
Overall Study
COMPLETED
|
54
|
55
|
55
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The International Diabetes Closed Loop (iDCL) Trial: Clinical Acceptance of the Artificial Pancreas (DCLP3 Extension)
Baseline characteristics by cohort
| Measure |
Closed Loop Control (CLC)
n=54 Participants
Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).
|
Predictive-Low Glucose Suspend (PLGS)
n=55 Participants
Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will use CLC through commercial availability of the device after the 3 months extension (Objective 3 of the trial).
|
SAP to CLC Group
n=55 Participants
Participants in this arm were transitioned to CLC (t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM) after the extension began. Participants in this arm had previously been randomized to Sensor-Augmented Pump (SAP) in the prior Pivotal Trial. This arm was not compared to the randomized groups CLC and PLGS that were randomized during the extension. This group met Objective 2 of the study.Participants in this arm will continue to use CLC through commercial availability of the device after the 3 months extension
|
Total
n=164 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
32 years
STANDARD_DEVIATION 14 • n=93 Participants
|
34 years
STANDARD_DEVIATION 17 • n=4 Participants
|
34 years
STANDARD_DEVIATION 17 • n=27 Participants
|
33 years
STANDARD_DEVIATION 16 • n=483 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=93 Participants
|
25 Participants
n=4 Participants
|
30 Participants
n=27 Participants
|
83 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=93 Participants
|
30 Participants
n=4 Participants
|
25 Participants
n=27 Participants
|
81 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
46 Participants
n=93 Participants
|
46 Participants
n=4 Participants
|
52 Participants
n=27 Participants
|
144 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Race · Non-White
|
7 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
17 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Race · Did Not Answer
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
|
Region of Enrollment
United States
|
54 participants
n=93 Participants
|
55 participants
n=4 Participants
|
55 participants
n=27 Participants
|
164 participants
n=483 Participants
|
|
Diabetes duration
|
18 years
n=93 Participants
|
16 years
n=4 Participants
|
16 years
n=27 Participants
|
17 years
n=483 Participants
|
|
BMI
|
26 kg/m^2
n=93 Participants
|
25 kg/m^2
n=4 Participants
|
26 kg/m^2
n=27 Participants
|
25 kg/m^2
n=483 Participants
|
|
Annual household income
<$50,000
|
5 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
12 Participants
n=483 Participants
|
|
Annual household income
$50,000 to < $100,000
|
8 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
18 Participants
n=27 Participants
|
39 Participants
n=483 Participants
|
|
Annual household income
>= $100,000
|
29 Participants
n=93 Participants
|
26 Participants
n=4 Participants
|
30 Participants
n=27 Participants
|
85 Participants
n=483 Participants
|
|
Annual household income
Did Not Answer
|
12 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
28 Participants
n=483 Participants
|
|
Highest education level
Less than a bachelor's degree
|
8 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
28 Participants
n=483 Participants
|
|
Highest education level
Bachelor's degree
|
26 Participants
n=93 Participants
|
23 Participants
n=4 Participants
|
21 Participants
n=27 Participants
|
70 Participants
n=483 Participants
|
|
Highest education level
Advanced degree
|
19 Participants
n=93 Participants
|
24 Participants
n=4 Participants
|
22 Participants
n=27 Participants
|
65 Participants
n=483 Participants
|
|
Highest education level
Did Not Answer
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Insurance
Private Insurance
|
49 Participants
n=93 Participants
|
51 Participants
n=4 Participants
|
50 Participants
n=27 Participants
|
150 Participants
n=483 Participants
|
|
Insurance
Other Insurance
|
2 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
9 Participants
n=483 Participants
|
|
Insurance
No Insurance
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
|
Insurance
Did Not Answer
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: 13 weeksThe primary exploratory outcome is time in target range 70-180 mg/dL measured by CGM comparing the randomized groups CLC vs PLGS. Results from SAP to CLC group is also included here without the primary intention of comparing to CLC vs PLGS groups.
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=54 Participants
Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).
|
Predictive-Low Glucose Suspend (PLGS)
n=55 Participants
Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will use CLC through commercial availability of the device after the 3 months extension (Objective 3 of the trial).
|
SAP to CLC Group
n=55 Participants
Participants in this arm were transitioned to CLC (t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM) after the extension began. Participants in this arm had previously been randomized to Sensor-Augmented Pump (SAP) in the primary trial (DCLP3 Pivotal Trial). This arm met Objective 2 of the study and was not compared to the CLC and PLGS groups that were randomized during the extension.
Participants in this arm will continue to use CLC through commercial availability of the device after the completion of the 3 months extension (Objective 3 of the trial).
|
|---|---|---|---|
|
Time in Target Range
|
67.6 percentage of time in range
Standard Deviation 12.6
|
60.4 percentage of time in range
Standard Deviation 17.1
|
69 percentage of time in range
Standard Deviation 11
|
SECONDARY outcome
Timeframe: 13 weeksCGM-measured % above 180 mg/dL
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=54 Participants
Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).
|
Predictive-Low Glucose Suspend (PLGS)
n=55 Participants
Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will use CLC through commercial availability of the device after the 3 months extension (Objective 3 of the trial).
|
SAP to CLC Group
n=55 Participants
Participants in this arm were transitioned to CLC (t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM) after the extension began. Participants in this arm had previously been randomized to Sensor-Augmented Pump (SAP) in the primary trial (DCLP3 Pivotal Trial). This arm met Objective 2 of the study and was not compared to the CLC and PLGS groups that were randomized during the extension.
Participants in this arm will continue to use CLC through commercial availability of the device after the completion of the 3 months extension (Objective 3 of the trial).
|
|---|---|---|---|
|
CGM Time Above 180
|
31 percentage of time
Standard Deviation 13
|
38 percentage of time
Standard Deviation 18
|
29 percentage of time
Standard Deviation 11
|
SECONDARY outcome
Timeframe: 13 weeksCGM-measured mean glucose
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=54 Participants
Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).
|
Predictive-Low Glucose Suspend (PLGS)
n=55 Participants
Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will use CLC through commercial availability of the device after the 3 months extension (Objective 3 of the trial).
|
SAP to CLC Group
n=55 Participants
Participants in this arm were transitioned to CLC (t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM) after the extension began. Participants in this arm had previously been randomized to Sensor-Augmented Pump (SAP) in the primary trial (DCLP3 Pivotal Trial). This arm met Objective 2 of the study and was not compared to the CLC and PLGS groups that were randomized during the extension.
Participants in this arm will continue to use CLC through commercial availability of the device after the completion of the 3 months extension (Objective 3 of the trial).
|
|---|---|---|---|
|
CGM Mean Glucose
|
160 mg/dL
Standard Deviation 20
|
170 mg/dL
Standard Deviation 30
|
158 mg/dL
Standard Deviation 17
|
SECONDARY outcome
Timeframe: 13 weeksCGM-measured % below 70 mg/dL
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=54 Participants
Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).
|
Predictive-Low Glucose Suspend (PLGS)
n=55 Participants
Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will use CLC through commercial availability of the device after the 3 months extension (Objective 3 of the trial).
|
SAP to CLC Group
n=55 Participants
Participants in this arm were transitioned to CLC (t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM) after the extension began. Participants in this arm had previously been randomized to Sensor-Augmented Pump (SAP) in the primary trial (DCLP3 Pivotal Trial). This arm met Objective 2 of the study and was not compared to the CLC and PLGS groups that were randomized during the extension.
Participants in this arm will continue to use CLC through commercial availability of the device after the completion of the 3 months extension (Objective 3 of the trial).
|
|---|---|---|---|
|
CGM Time Below 70
|
0.53 percentage of time
Standard Deviation 0.34
|
0.59 percentage of time
Standard Deviation 0.37
|
1.76 percentage of time
Standard Deviation 1.07
|
SECONDARY outcome
Timeframe: 13 weeksCGM-measured % below 54 mg/dL
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=54 Participants
Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).
|
Predictive-Low Glucose Suspend (PLGS)
n=55 Participants
Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will use CLC through commercial availability of the device after the 3 months extension (Objective 3 of the trial).
|
SAP to CLC Group
n=55 Participants
Participants in this arm were transitioned to CLC (t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM) after the extension began. Participants in this arm had previously been randomized to Sensor-Augmented Pump (SAP) in the primary trial (DCLP3 Pivotal Trial). This arm met Objective 2 of the study and was not compared to the CLC and PLGS groups that were randomized during the extension.
Participants in this arm will continue to use CLC through commercial availability of the device after the completion of the 3 months extension (Objective 3 of the trial).
|
|---|---|---|---|
|
CGM Time Below 54
|
0.2 percentage of time
Interval 0.07 to 0.48
|
0.22 percentage of time
Interval 0.06 to 0.46
|
0.19 percentage of time
Interval 0.08 to 0.36
|
SECONDARY outcome
Timeframe: 13 weeksCGM-measured % in range 70-140 mg/dL
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=54 Participants
Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).
|
Predictive-Low Glucose Suspend (PLGS)
n=55 Participants
Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will use CLC through commercial availability of the device after the 3 months extension (Objective 3 of the trial).
|
SAP to CLC Group
n=55 Participants
Participants in this arm were transitioned to CLC (t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM) after the extension began. Participants in this arm had previously been randomized to Sensor-Augmented Pump (SAP) in the primary trial (DCLP3 Pivotal Trial). This arm met Objective 2 of the study and was not compared to the CLC and PLGS groups that were randomized during the extension.
Participants in this arm will continue to use CLC through commercial availability of the device after the completion of the 3 months extension (Objective 3 of the trial).
|
|---|---|---|---|
|
CGM Time in Range 70-140 mg/dL
|
42 percentage of time
Standard Deviation 12.5
|
37.1 percentage of time
Standard Deviation 14.2
|
45 percentage of time
Standard Deviation 10
|
SECONDARY outcome
Timeframe: 13 weeksCGM measured glucose variability measured with the coefficient of variation (CV)
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=54 Participants
Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).
|
Predictive-Low Glucose Suspend (PLGS)
n=55 Participants
Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will use CLC through commercial availability of the device after the 3 months extension (Objective 3 of the trial).
|
SAP to CLC Group
n=55 Participants
Participants in this arm were transitioned to CLC (t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM) after the extension began. Participants in this arm had previously been randomized to Sensor-Augmented Pump (SAP) in the primary trial (DCLP3 Pivotal Trial). This arm met Objective 2 of the study and was not compared to the CLC and PLGS groups that were randomized during the extension.
Participants in this arm will continue to use CLC through commercial availability of the device after the completion of the 3 months extension (Objective 3 of the trial).
|
|---|---|---|---|
|
Coefficient of Variation
|
34 percentage SD of Mean
Standard Deviation 4
|
35 percentage SD of Mean
Standard Deviation 5
|
35 percentage SD of Mean
Standard Deviation 5
|
SECONDARY outcome
Timeframe: 13 weeksCGM measured glucose variability measured with the standard deviation (SD)
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=54 Participants
Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).
|
Predictive-Low Glucose Suspend (PLGS)
n=55 Participants
Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will use CLC through commercial availability of the device after the 3 months extension (Objective 3 of the trial).
|
SAP to CLC Group
n=55 Participants
Participants in this arm were transitioned to CLC (t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM) after the extension began. Participants in this arm had previously been randomized to Sensor-Augmented Pump (SAP) in the primary trial (DCLP3 Pivotal Trial). This arm met Objective 2 of the study and was not compared to the CLC and PLGS groups that were randomized during the extension.
Participants in this arm will continue to use CLC through commercial availability of the device after the completion of the 3 months extension (Objective 3 of the trial).
|
|---|---|---|---|
|
Standard Deviation
|
55 mg/dL
Standard Deviation 12
|
60 mg/dL
Standard Deviation 15
|
56 mg/dL
Standard Deviation 12
|
SECONDARY outcome
Timeframe: 13 weeksCGM-measured % below 60 mg/dL
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=54 Participants
Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).
|
Predictive-Low Glucose Suspend (PLGS)
n=55 Participants
Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will use CLC through commercial availability of the device after the 3 months extension (Objective 3 of the trial).
|
SAP to CLC Group
n=55 Participants
Participants in this arm were transitioned to CLC (t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM) after the extension began. Participants in this arm had previously been randomized to Sensor-Augmented Pump (SAP) in the primary trial (DCLP3 Pivotal Trial). This arm met Objective 2 of the study and was not compared to the CLC and PLGS groups that were randomized during the extension.
Participants in this arm will continue to use CLC through commercial availability of the device after the completion of the 3 months extension (Objective 3 of the trial).
|
|---|---|---|---|
|
CGM Time Below 60
|
0.43 percentage of time
Interval 0.19 to 0.97
|
0.46 percentage of time
Interval 0.17 to 0.96
|
0.51 percentage of time
Interval 0.3 to 0.78
|
SECONDARY outcome
Timeframe: 13 weeksLow blood glucose index by CGM with higher index indicating higher risk of hypoglycemia. Values \<1 suggest minimal risk. Index of risk of low blood glucose excursion based on a standard formula for non-linear transformation of the blood glucose scale (Kovatchev BP, Cox DJ, Gonder-Frederick LA, Young-Hyman D, Schlundt D, Clarke WL: Assessment of risk for severe hypoglycemia among adults with IDDM: validation of the low blood glucose index. Diabetes Care 21:1870-1875, 1998)
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=54 Participants
Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).
|
Predictive-Low Glucose Suspend (PLGS)
n=55 Participants
Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will use CLC through commercial availability of the device after the 3 months extension (Objective 3 of the trial).
|
SAP to CLC Group
n=55 Participants
Participants in this arm were transitioned to CLC (t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM) after the extension began. Participants in this arm had previously been randomized to Sensor-Augmented Pump (SAP) in the primary trial (DCLP3 Pivotal Trial). This arm met Objective 2 of the study and was not compared to the CLC and PLGS groups that were randomized during the extension.
Participants in this arm will continue to use CLC through commercial availability of the device after the completion of the 3 months extension (Objective 3 of the trial).
|
|---|---|---|---|
|
LBGI
|
0.53 index
Standard Deviation 0.34
|
0.59 index
Standard Deviation 0.37
|
0.54 index
Standard Deviation 0.24
|
SECONDARY outcome
Timeframe: 13 weeksCGM-measured events of at least 15 consecutive minutes \<70 mg/dL
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=54 Participants
Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).
|
Predictive-Low Glucose Suspend (PLGS)
n=55 Participants
Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will use CLC through commercial availability of the device after the 3 months extension (Objective 3 of the trial).
|
SAP to CLC Group
n=55 Participants
Participants in this arm were transitioned to CLC (t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM) after the extension began. Participants in this arm had previously been randomized to Sensor-Augmented Pump (SAP) in the primary trial (DCLP3 Pivotal Trial). This arm met Objective 2 of the study and was not compared to the CLC and PLGS groups that were randomized during the extension.
Participants in this arm will continue to use CLC through commercial availability of the device after the completion of the 3 months extension (Objective 3 of the trial).
|
|---|---|---|---|
|
CGM Hypoglycemia Events
|
3.0 Events per Week
Interval 1.5 to 4.9
|
3.1 Events per Week
Interval 1.6 to 5.3
|
3.8 Events per Week
Interval 2.5 to 4.8
|
SECONDARY outcome
Timeframe: 13 weeksCGM-measured % \>250 mg/dL
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=54 Participants
Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).
|
Predictive-Low Glucose Suspend (PLGS)
n=55 Participants
Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will use CLC through commercial availability of the device after the 3 months extension (Objective 3 of the trial).
|
SAP to CLC Group
n=55 Participants
Participants in this arm were transitioned to CLC (t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM) after the extension began. Participants in this arm had previously been randomized to Sensor-Augmented Pump (SAP) in the primary trial (DCLP3 Pivotal Trial). This arm met Objective 2 of the study and was not compared to the CLC and PLGS groups that were randomized during the extension.
Participants in this arm will continue to use CLC through commercial availability of the device after the completion of the 3 months extension (Objective 3 of the trial).
|
|---|---|---|---|
|
CGM Time >250
|
7 percentage of time
Standard Deviation 6.5
|
13.6 percentage of time
Standard Deviation 12.4
|
7.8 percentage of time
Standard Deviation 6.6
|
SECONDARY outcome
Timeframe: 13 weeksCGM-measured % \>300 mg/dL
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=54 Participants
Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).
|
Predictive-Low Glucose Suspend (PLGS)
n=55 Participants
Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will use CLC through commercial availability of the device after the 3 months extension (Objective 3 of the trial).
|
SAP to CLC Group
n=55 Participants
Participants in this arm were transitioned to CLC (t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM) after the extension began. Participants in this arm had previously been randomized to Sensor-Augmented Pump (SAP) in the primary trial (DCLP3 Pivotal Trial). This arm met Objective 2 of the study and was not compared to the CLC and PLGS groups that were randomized during the extension.
Participants in this arm will continue to use CLC through commercial availability of the device after the completion of the 3 months extension (Objective 3 of the trial).
|
|---|---|---|---|
|
CGM Time >300
|
2.3 percentage of time
Standard Deviation 3.4
|
5.2 percentage of time
Standard Deviation 6.3
|
2.7 percentage of time
Standard Deviation 3.5
|
SECONDARY outcome
Timeframe: 13 weeksHigh blood glucose index by CGM with higher values indicating higher risk of hyperglycemia. Index of risk of high blood glucose excursion based on a standard formula for non-linear transformation of the blood glucose scale (Kovatchev BP, Cox DJ, Kumar A, Gonder-Frederick L, Clarke WL. Algorithmic evaluation of metabolic control and risk of severe hypoglycemia in type 1 and type 2 diabetes using self-monitoring blood glucose data. Diabetes Technol Ther 2003;5:817-828pmid:14633347)
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=54 Participants
Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).
|
Predictive-Low Glucose Suspend (PLGS)
n=55 Participants
Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will use CLC through commercial availability of the device after the 3 months extension (Objective 3 of the trial).
|
SAP to CLC Group
n=55 Participants
Participants in this arm were transitioned to CLC (t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM) after the extension began. Participants in this arm had previously been randomized to Sensor-Augmented Pump (SAP) in the primary trial (DCLP3 Pivotal Trial). This arm met Objective 2 of the study and was not compared to the CLC and PLGS groups that were randomized during the extension.
Participants in this arm will continue to use CLC through commercial availability of the device after the completion of the 3 months extension (Objective 3 of the trial).
|
|---|---|---|---|
|
HBGI
|
6.4 index
Standard Deviation 3.1
|
9.2 index
Standard Deviation 5.3
|
6.6 index
Standard Deviation 3.0
|
SECONDARY outcome
Timeframe: 13 weeksHbA1c at 13 weeks.
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=54 Participants
Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).
|
Predictive-Low Glucose Suspend (PLGS)
n=55 Participants
Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will use CLC through commercial availability of the device after the 3 months extension (Objective 3 of the trial).
|
SAP to CLC Group
n=55 Participants
Participants in this arm were transitioned to CLC (t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM) after the extension began. Participants in this arm had previously been randomized to Sensor-Augmented Pump (SAP) in the primary trial (DCLP3 Pivotal Trial). This arm met Objective 2 of the study and was not compared to the CLC and PLGS groups that were randomized during the extension.
Participants in this arm will continue to use CLC through commercial availability of the device after the completion of the 3 months extension (Objective 3 of the trial).
|
|---|---|---|---|
|
HbA1c at 13 Weeks
|
7.18 % of glycated hemoglobin
Standard Deviation 0.80
|
7.53 % of glycated hemoglobin
Standard Deviation 1.14
|
7.09 % of glycated hemoglobin
Standard Deviation 0.74
|
SECONDARY outcome
Timeframe: 13 weeksHbA1c \<7.0% at 13 weeks.
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=54 Participants
Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).
|
Predictive-Low Glucose Suspend (PLGS)
n=55 Participants
Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will use CLC through commercial availability of the device after the 3 months extension (Objective 3 of the trial).
|
SAP to CLC Group
n=55 Participants
Participants in this arm were transitioned to CLC (t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM) after the extension began. Participants in this arm had previously been randomized to Sensor-Augmented Pump (SAP) in the primary trial (DCLP3 Pivotal Trial). This arm met Objective 2 of the study and was not compared to the CLC and PLGS groups that were randomized during the extension.
Participants in this arm will continue to use CLC through commercial availability of the device after the completion of the 3 months extension (Objective 3 of the trial).
|
|---|---|---|---|
|
HbA1c <7.0% at 13 Weeks
|
23 Participants
|
15 Participants
|
26 Participants
|
SECONDARY outcome
Timeframe: 13 weeksHbA1c \<7.5% at 13 weeks.
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=54 Participants
Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).
|
Predictive-Low Glucose Suspend (PLGS)
n=55 Participants
Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will use CLC through commercial availability of the device after the 3 months extension (Objective 3 of the trial).
|
SAP to CLC Group
n=55 Participants
Participants in this arm were transitioned to CLC (t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM) after the extension began. Participants in this arm had previously been randomized to Sensor-Augmented Pump (SAP) in the primary trial (DCLP3 Pivotal Trial). This arm met Objective 2 of the study and was not compared to the CLC and PLGS groups that were randomized during the extension.
Participants in this arm will continue to use CLC through commercial availability of the device after the completion of the 3 months extension (Objective 3 of the trial).
|
|---|---|---|---|
|
HbA1c <7.5% at 13 Weeks
|
35 Participants
|
32 Participants
|
39 Participants
|
SECONDARY outcome
Timeframe: 13 weeksHbA1c change from baseline to 13 weeks \>0.5%.
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=54 Participants
Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).
|
Predictive-Low Glucose Suspend (PLGS)
n=55 Participants
Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will use CLC through commercial availability of the device after the 3 months extension (Objective 3 of the trial).
|
SAP to CLC Group
n=55 Participants
Participants in this arm were transitioned to CLC (t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM) after the extension began. Participants in this arm had previously been randomized to Sensor-Augmented Pump (SAP) in the primary trial (DCLP3 Pivotal Trial). This arm met Objective 2 of the study and was not compared to the CLC and PLGS groups that were randomized during the extension.
Participants in this arm will continue to use CLC through commercial availability of the device after the completion of the 3 months extension (Objective 3 of the trial).
|
|---|---|---|---|
|
HbA1c Change From Baseline to 13 Weeks >0.5%
|
1 Participants
|
2 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: 13 weeksHbA1c change from baseline to 13 weeks \>1.0%.
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=54 Participants
Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).
|
Predictive-Low Glucose Suspend (PLGS)
n=55 Participants
Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will use CLC through commercial availability of the device after the 3 months extension (Objective 3 of the trial).
|
SAP to CLC Group
n=55 Participants
Participants in this arm were transitioned to CLC (t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM) after the extension began. Participants in this arm had previously been randomized to Sensor-Augmented Pump (SAP) in the primary trial (DCLP3 Pivotal Trial). This arm met Objective 2 of the study and was not compared to the CLC and PLGS groups that were randomized during the extension.
Participants in this arm will continue to use CLC through commercial availability of the device after the completion of the 3 months extension (Objective 3 of the trial).
|
|---|---|---|---|
|
HbA1c Change From Baseline to 13 Weeks >1.0%
|
0 Participants
|
0 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 13 weeksHbA1c relative change from baseline to 13 weeks \>10%.
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=54 Participants
Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).
|
Predictive-Low Glucose Suspend (PLGS)
n=55 Participants
Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will use CLC through commercial availability of the device after the 3 months extension (Objective 3 of the trial).
|
SAP to CLC Group
n=55 Participants
Participants in this arm were transitioned to CLC (t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM) after the extension began. Participants in this arm had previously been randomized to Sensor-Augmented Pump (SAP) in the primary trial (DCLP3 Pivotal Trial). This arm met Objective 2 of the study and was not compared to the CLC and PLGS groups that were randomized during the extension.
Participants in this arm will continue to use CLC through commercial availability of the device after the completion of the 3 months extension (Objective 3 of the trial).
|
|---|---|---|---|
|
HbA1c Relative Change From Baseline to 13 Weeks >10%
|
0 Participants
|
0 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: 13 weeksHbA1c change from baseline to 13 weeks \>1.0% or HbA1c \<7.0% at 13 weeks.
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=54 Participants
Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).
|
Predictive-Low Glucose Suspend (PLGS)
n=55 Participants
Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will use CLC through commercial availability of the device after the 3 months extension (Objective 3 of the trial).
|
SAP to CLC Group
n=55 Participants
Participants in this arm were transitioned to CLC (t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM) after the extension began. Participants in this arm had previously been randomized to Sensor-Augmented Pump (SAP) in the primary trial (DCLP3 Pivotal Trial). This arm met Objective 2 of the study and was not compared to the CLC and PLGS groups that were randomized during the extension.
Participants in this arm will continue to use CLC through commercial availability of the device after the completion of the 3 months extension (Objective 3 of the trial).
|
|---|---|---|---|
|
HbA1c Change From Baseline to 13 Weeks >1.0% or HbA1C <7.0% at 13 Weeks
|
23 Participants
|
15 Participants
|
30 Participants
|
SECONDARY outcome
Timeframe: 13 weeksPopulation: Adults
Fear of Hypoglycemia Survey (HFS-II) total score and 3 sub scales (5 point scale with never to almost always) For adults, teens and parents items on this survey are rated on a 5 point Likert scale from never (0) to almost always (4). The survey is scored by summing item responses. Fear of Hypoglycemia Survey (HFS-II) for adults has a total score that is summed from the two subscale scores (33 items) and ranges from 0 to 132 with higher scores indicating greater degrees of fear of hypoglycemia.
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=40 Participants
Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).
|
Predictive-Low Glucose Suspend (PLGS)
n=42 Participants
Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will use CLC through commercial availability of the device after the 3 months extension (Objective 3 of the trial).
|
SAP to CLC Group
n=41 Participants
Participants in this arm were transitioned to CLC (t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM) after the extension began. Participants in this arm had previously been randomized to Sensor-Augmented Pump (SAP) in the primary trial (DCLP3 Pivotal Trial). This arm met Objective 2 of the study and was not compared to the CLC and PLGS groups that were randomized during the extension.
Participants in this arm will continue to use CLC through commercial availability of the device after the completion of the 3 months extension (Objective 3 of the trial).
|
|---|---|---|---|
|
HFS-II Adult
|
29 total score on a scale
Standard Deviation 11
|
35 total score on a scale
Standard Deviation 16
|
33 total score on a scale
Standard Deviation 14
|
SECONDARY outcome
Timeframe: 13 weeksPopulation: Teens
Fear of Hypoglycemia Survey (HFS-II) total score and 3 sub scales (5 point scale with never to almost always) For adults, teens and parents items on this survey are rated on a 5 point Likert scale from never (0) to almost always (4). The survey is scored by summing item responses.The teen survey has a total of 25 items and the range of Total scores is 0 to 100.
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=14 Participants
Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).
|
Predictive-Low Glucose Suspend (PLGS)
n=13 Participants
Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will use CLC through commercial availability of the device after the 3 months extension (Objective 3 of the trial).
|
SAP to CLC Group
n=12 Participants
Participants in this arm were transitioned to CLC (t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM) after the extension began. Participants in this arm had previously been randomized to Sensor-Augmented Pump (SAP) in the primary trial (DCLP3 Pivotal Trial). This arm met Objective 2 of the study and was not compared to the CLC and PLGS groups that were randomized during the extension.
Participants in this arm will continue to use CLC through commercial availability of the device after the completion of the 3 months extension (Objective 3 of the trial).
|
|---|---|---|---|
|
HFS-II Teen
|
35 total score on a scale
Standard Deviation 9
|
30 total score on a scale
Standard Deviation 12
|
30 total score on a scale
Standard Deviation 13
|
SECONDARY outcome
Timeframe: 13 weeksPopulation: Parent
Fear of Hypoglycemia Survey (HFS-II) total score and 3 sub scales (5 point scale with never to almost always) For adults, teens and parents items on this survey are rated on a 5 point Likert scale from never (0) to almost always (4). The parent version of the survey has a total of 26 items with Total scores that range from 0 to 108.
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=14 Participants
Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).
|
Predictive-Low Glucose Suspend (PLGS)
n=13 Participants
Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will use CLC through commercial availability of the device after the 3 months extension (Objective 3 of the trial).
|
SAP to CLC Group
n=12 Participants
Participants in this arm were transitioned to CLC (t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM) after the extension began. Participants in this arm had previously been randomized to Sensor-Augmented Pump (SAP) in the primary trial (DCLP3 Pivotal Trial). This arm met Objective 2 of the study and was not compared to the CLC and PLGS groups that were randomized during the extension.
Participants in this arm will continue to use CLC through commercial availability of the device after the completion of the 3 months extension (Objective 3 of the trial).
|
|---|---|---|---|
|
HFS-II Parents
|
35 total score on a scale
Standard Deviation 12
|
40 total score on a scale
Standard Deviation 18
|
37 total score on a scale
Standard Deviation 14
|
SECONDARY outcome
Timeframe: 13 weeksHyperglycemia Avoidance Scale total score is the sum of 21 items rated on a 4 point Likert scale from 0 (never) to 4 (almost always) and ranges from 0 to 84 with a higher score indicating greater degrees of avoiding hyperglycemia.
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=54 Participants
Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).
|
Predictive-Low Glucose Suspend (PLGS)
n=55 Participants
Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will use CLC through commercial availability of the device after the 3 months extension (Objective 3 of the trial).
|
SAP to CLC Group
n=53 Participants
Participants in this arm were transitioned to CLC (t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM) after the extension began. Participants in this arm had previously been randomized to Sensor-Augmented Pump (SAP) in the primary trial (DCLP3 Pivotal Trial). This arm met Objective 2 of the study and was not compared to the CLC and PLGS groups that were randomized during the extension.
Participants in this arm will continue to use CLC through commercial availability of the device after the completion of the 3 months extension (Objective 3 of the trial).
|
|---|---|---|---|
|
Hyperglycemia Avoidance Scale
|
37 total score on a scale
Standard Deviation 9
|
37 total score on a scale
Standard Deviation 11
|
36 total score on a scale
Standard Deviation 10
|
SECONDARY outcome
Timeframe: 13 weeksDiabetes Distress Scale for adults has 28 items rated on a 6 point Likert scale that ranges from 1 (not a problem) to 6 (a very serious problem). The total score is the mean of the sum of responses and ranges from 1 to 6 where a higher score indicates greater degrees of diabetes distress.
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=54 Participants
Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).
|
Predictive-Low Glucose Suspend (PLGS)
n=55 Participants
Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will use CLC through commercial availability of the device after the 3 months extension (Objective 3 of the trial).
|
SAP to CLC Group
n=53 Participants
Participants in this arm were transitioned to CLC (t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM) after the extension began. Participants in this arm had previously been randomized to Sensor-Augmented Pump (SAP) in the primary trial (DCLP3 Pivotal Trial). This arm met Objective 2 of the study and was not compared to the CLC and PLGS groups that were randomized during the extension.
Participants in this arm will continue to use CLC through commercial availability of the device after the completion of the 3 months extension (Objective 3 of the trial).
|
|---|---|---|---|
|
Diabetes Distress Scale
|
1.8 total score on a scale
Standard Deviation 0.7
|
1.7 total score on a scale
Standard Deviation 0.7
|
1.7 total score on a scale
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: 13 weeksPopulation: Reporting first item on the scale: exercise
Hypoglycemia Confidence Scale has 9 items which are self-rated on a 4-point Likert Scale ranging from 1 (not confident at all) to 4 (very confident) with higher scores indicating higher confidence in dealing with hypoglycemia. A single score is computed by calculating the mean of the sum of all items and ranges from 1 to 4.
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=54 Participants
Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).
|
Predictive-Low Glucose Suspend (PLGS)
n=55 Participants
Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will use CLC through commercial availability of the device after the 3 months extension (Objective 3 of the trial).
|
SAP to CLC Group
n=53 Participants
Participants in this arm were transitioned to CLC (t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM) after the extension began. Participants in this arm had previously been randomized to Sensor-Augmented Pump (SAP) in the primary trial (DCLP3 Pivotal Trial). This arm met Objective 2 of the study and was not compared to the CLC and PLGS groups that were randomized during the extension.
Participants in this arm will continue to use CLC through commercial availability of the device after the completion of the 3 months extension (Objective 3 of the trial).
|
|---|---|---|---|
|
Hypoglycemia Confidence Scale
|
2.0 score on a scale
Interval 1.0 to 4.0
|
2.1 score on a scale
Interval 2.0 to 4.0
|
1.9 score on a scale
Interval 1.0 to 4.0
|
SECONDARY outcome
Timeframe: 13 weeksClarke Hypoglycemia Awareness Scores (0-7 score with higher scores associated with impaired awareness)
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=54 Participants
Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).
|
Predictive-Low Glucose Suspend (PLGS)
n=55 Participants
Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will use CLC through commercial availability of the device after the 3 months extension (Objective 3 of the trial).
|
SAP to CLC Group
n=53 Participants
Participants in this arm were transitioned to CLC (t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM) after the extension began. Participants in this arm had previously been randomized to Sensor-Augmented Pump (SAP) in the primary trial (DCLP3 Pivotal Trial). This arm met Objective 2 of the study and was not compared to the CLC and PLGS groups that were randomized during the extension.
Participants in this arm will continue to use CLC through commercial availability of the device after the completion of the 3 months extension (Objective 3 of the trial).
|
|---|---|---|---|
|
Clarke Hypoglycemia Awareness Scores
|
1 total score on a scale
Interval 0.0 to 3.0
|
1 total score on a scale
Interval 1.0 to 3.0
|
1 total score on a scale
Interval 0.0 to 3.0
|
SECONDARY outcome
Timeframe: 13 weeksPopulation: Adults
The INSPIRE questionnaire assesses user expectations and experiences with Insulin Delivery Systems: Perceptions, Ideas, Reflections, Expectations (INSPIRE). Survey total scores are computed by calculating the mean of the sum of all item ratings then multiplying the mean by 25 to scale the score to a range from 0 to 100. Higher scores indicate a more positive perception of insulin delivery systems. Items are rated on a 5 point Likert scale ranging from 0 (strongly disagree) to 4 (strongly agree). The Adult survey has 22 items.
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=40 Participants
Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).
|
Predictive-Low Glucose Suspend (PLGS)
n=42 Participants
Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will use CLC through commercial availability of the device after the 3 months extension (Objective 3 of the trial).
|
SAP to CLC Group
n=41 Participants
Participants in this arm were transitioned to CLC (t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM) after the extension began. Participants in this arm had previously been randomized to Sensor-Augmented Pump (SAP) in the primary trial (DCLP3 Pivotal Trial). This arm met Objective 2 of the study and was not compared to the CLC and PLGS groups that were randomized during the extension.
Participants in this arm will continue to use CLC through commercial availability of the device after the completion of the 3 months extension (Objective 3 of the trial).
|
|---|---|---|---|
|
INSPIRE Survey Scores- Adults
|
87 total score on a scale
Standard Deviation 13
|
87 total score on a scale
Standard Deviation 13
|
84 total score on a scale
Standard Deviation 17
|
SECONDARY outcome
Timeframe: 13 weeksPopulation: Teens
The INSPIRE questionnaire assesses user expectations and experiences with Insulin Delivery Systems: Perceptions, Ideas, Reflections, Expectations (INSPIRE). Survey total scores are computed by calculating the mean of the sum of all item ratings then multiplying the mean by 25 to scale the score to a range from 0 to 100. Higher scores indicate a more positive perception of insulin delivery systems. Items are rated on a 5 point Likert scale ranging from 0 (strongly disagree) to 4 (strongly agree). The Teens/Adolescents survey has 17 items.
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=14 Participants
Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).
|
Predictive-Low Glucose Suspend (PLGS)
n=13 Participants
Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will use CLC through commercial availability of the device after the 3 months extension (Objective 3 of the trial).
|
SAP to CLC Group
n=12 Participants
Participants in this arm were transitioned to CLC (t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM) after the extension began. Participants in this arm had previously been randomized to Sensor-Augmented Pump (SAP) in the primary trial (DCLP3 Pivotal Trial). This arm met Objective 2 of the study and was not compared to the CLC and PLGS groups that were randomized during the extension.
Participants in this arm will continue to use CLC through commercial availability of the device after the completion of the 3 months extension (Objective 3 of the trial).
|
|---|---|---|---|
|
INSPIRE Survey Scores- Teens
|
80 total score on a scale
Standard Deviation 16
|
89 total score on a scale
Standard Deviation 15
|
77 total score on a scale
Standard Deviation 16
|
SECONDARY outcome
Timeframe: 13 weeksPopulation: Parent.
The INSPIRE questionnaire assesses user expectations and experiences with Insulin Delivery Systems: Perceptions, Ideas, Reflections, Expectations (INSPIRE). Survey total scores are computed by calculating the mean of the sum of all item ratings then multiplying the mean by 25 to scale the score to a range from 0 to 100. Higher scores indicate a more positive perception of insulin delivery systems. Items are rated on a 5 point Likert scale ranging from 0 (strongly disagree) to 4 (strongly agree). The Parent survey has 21 items.
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=14 Participants
Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).
|
Predictive-Low Glucose Suspend (PLGS)
n=13 Participants
Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will use CLC through commercial availability of the device after the 3 months extension (Objective 3 of the trial).
|
SAP to CLC Group
n=12 Participants
Participants in this arm were transitioned to CLC (t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM) after the extension began. Participants in this arm had previously been randomized to Sensor-Augmented Pump (SAP) in the primary trial (DCLP3 Pivotal Trial). This arm met Objective 2 of the study and was not compared to the CLC and PLGS groups that were randomized during the extension.
Participants in this arm will continue to use CLC through commercial availability of the device after the completion of the 3 months extension (Objective 3 of the trial).
|
|---|---|---|---|
|
INSPIRE Survey Scores- Parents
|
86 total score on a scale
Standard Deviation 17
|
87 total score on a scale
Standard Deviation 13
|
86 total score on a scale
Standard Deviation 11
|
SECONDARY outcome
Timeframe: 13 weeksSystem Usability Scores (SUS)-composite score from 0 to 100 with higher scores indicating better perceived usability
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=54 Participants
Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).
|
Predictive-Low Glucose Suspend (PLGS)
n=54 Participants
Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will use CLC through commercial availability of the device after the 3 months extension (Objective 3 of the trial).
|
SAP to CLC Group
n=53 Participants
Participants in this arm were transitioned to CLC (t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM) after the extension began. Participants in this arm had previously been randomized to Sensor-Augmented Pump (SAP) in the primary trial (DCLP3 Pivotal Trial). This arm met Objective 2 of the study and was not compared to the CLC and PLGS groups that were randomized during the extension.
Participants in this arm will continue to use CLC through commercial availability of the device after the completion of the 3 months extension (Objective 3 of the trial).
|
|---|---|---|---|
|
System Usability Scores (SUS)
|
85 total score on a scale
Standard Deviation 12.3
|
86.6 total score on a scale
Standard Deviation 11.3
|
85.2 total score on a scale
Standard Deviation 16.9
|
SECONDARY outcome
Timeframe: 13 weeksTechnology Acceptance Survey measures the user's perceptions regarding the burdens and the barriers associated with a technology with a higher score indicates increased technology acceptance. There total score uses 37 items with items are rated on a 5 point scale ranging from 1 (strongly disagree) to 5 (strongly agree) for total score range of 37-185.
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=54 Participants
Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).
|
Predictive-Low Glucose Suspend (PLGS)
n=54 Participants
Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will use CLC through commercial availability of the device after the 3 months extension (Objective 3 of the trial).
|
SAP to CLC Group
n=53 Participants
Participants in this arm were transitioned to CLC (t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM) after the extension began. Participants in this arm had previously been randomized to Sensor-Augmented Pump (SAP) in the primary trial (DCLP3 Pivotal Trial). This arm met Objective 2 of the study and was not compared to the CLC and PLGS groups that were randomized during the extension.
Participants in this arm will continue to use CLC through commercial availability of the device after the completion of the 3 months extension (Objective 3 of the trial).
|
|---|---|---|---|
|
Technology Acceptance Questionnaire
|
151 total score on a scale
Standard Deviation 17
|
149 total score on a scale
Standard Deviation 25
|
145 total score on a scale
Standard Deviation 28
|
SECONDARY outcome
Timeframe: 13 weeksPopulation: Data not available in all participants
Total Daily Insulin (units/kg)
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=54 Participants
Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).
|
Predictive-Low Glucose Suspend (PLGS)
n=55 Participants
Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will use CLC through commercial availability of the device after the 3 months extension (Objective 3 of the trial).
|
SAP to CLC Group
n=53 Participants
Participants in this arm were transitioned to CLC (t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM) after the extension began. Participants in this arm had previously been randomized to Sensor-Augmented Pump (SAP) in the primary trial (DCLP3 Pivotal Trial). This arm met Objective 2 of the study and was not compared to the CLC and PLGS groups that were randomized during the extension.
Participants in this arm will continue to use CLC through commercial availability of the device after the completion of the 3 months extension (Objective 3 of the trial).
|
|---|---|---|---|
|
Total Daily Insulin
Baseline
|
0.59 Units of insulin per kg
Interval 0.49 to 0.86
|
0.68 Units of insulin per kg
Interval 0.46 to 0.93
|
0.62 Units of insulin per kg
Interval 0.52 to 0.9
|
|
Total Daily Insulin
At 13-week Follow Up
|
0.62 Units of insulin per kg
Interval 0.5 to 0.84
|
0.67 Units of insulin per kg
Interval 0.48 to 0.88
|
0.64 Units of insulin per kg
Interval 0.52 to 0.86
|
SECONDARY outcome
Timeframe: 13 weeksBasal:Bolus Insulin Ratio.
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=54 Participants
Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).
|
Predictive-Low Glucose Suspend (PLGS)
n=55 Participants
Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will use CLC through commercial availability of the device after the 3 months extension (Objective 3 of the trial).
|
SAP to CLC Group
n=53 Participants
Participants in this arm were transitioned to CLC (t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM) after the extension began. Participants in this arm had previously been randomized to Sensor-Augmented Pump (SAP) in the primary trial (DCLP3 Pivotal Trial). This arm met Objective 2 of the study and was not compared to the CLC and PLGS groups that were randomized during the extension.
Participants in this arm will continue to use CLC through commercial availability of the device after the completion of the 3 months extension (Objective 3 of the trial).
|
|---|---|---|---|
|
Basal:Bolus Insulin Ratio
Baseline
|
0.9 Basal:Bolus Ratio
Interval 0.7 to 1.2
|
0.8 Basal:Bolus Ratio
Interval 0.6 to 1.2
|
0.88 Basal:Bolus Ratio
Interval 0.69 to 1.27
|
|
Basal:Bolus Insulin Ratio
At 13-week Follow Up
|
1.0 Basal:Bolus Ratio
Interval 0.8 to 1.2
|
0.9 Basal:Bolus Ratio
Interval 0.6 to 1.3
|
0.96 Basal:Bolus Ratio
Interval 0.71 to 1.32
|
SECONDARY outcome
Timeframe: 13 weeksPopulation: Data not available in all participants.
Weight (kg)
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=54 Participants
Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).
|
Predictive-Low Glucose Suspend (PLGS)
n=55 Participants
Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will use CLC through commercial availability of the device after the 3 months extension (Objective 3 of the trial).
|
SAP to CLC Group
n=55 Participants
Participants in this arm were transitioned to CLC (t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM) after the extension began. Participants in this arm had previously been randomized to Sensor-Augmented Pump (SAP) in the primary trial (DCLP3 Pivotal Trial). This arm met Objective 2 of the study and was not compared to the CLC and PLGS groups that were randomized during the extension.
Participants in this arm will continue to use CLC through commercial availability of the device after the completion of the 3 months extension (Objective 3 of the trial).
|
|---|---|---|---|
|
Weight
Baseline
|
77.2 kg
Interval 66.3 to 93.4
|
73.0 kg
Interval 65.5 to 87.8
|
74 kg
Interval 62.0 to 86.0
|
|
Weight
At 13-week Follow Up
|
79.2 kg
Interval 65.9 to 93.4
|
72.8 kg
Interval 65.8 to 87.8
|
75 kg
Interval 64.0 to 87.0
|
SECONDARY outcome
Timeframe: 13 weeksPopulation: Data not available in all participants
Body Mass Index (BMI) kg/m2
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=54 Participants
Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).
|
Predictive-Low Glucose Suspend (PLGS)
n=55 Participants
Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will use CLC through commercial availability of the device after the 3 months extension (Objective 3 of the trial).
|
SAP to CLC Group
n=55 Participants
Participants in this arm were transitioned to CLC (t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM) after the extension began. Participants in this arm had previously been randomized to Sensor-Augmented Pump (SAP) in the primary trial (DCLP3 Pivotal Trial). This arm met Objective 2 of the study and was not compared to the CLC and PLGS groups that were randomized during the extension.
Participants in this arm will continue to use CLC through commercial availability of the device after the completion of the 3 months extension (Objective 3 of the trial).
|
|---|---|---|---|
|
BMI
Baseline
|
25.7 kg/m^2
Interval 23.4 to 30.0
|
25.1 kg/m^2
Interval 22.6 to 28.5
|
26 kg/m^2
Interval 22.0 to 29.0
|
|
BMI
At 13-week Follow Up
|
25.6 kg/m^2
Interval 23.3 to 29.2
|
25.1 kg/m^2
Interval 23.1 to 28.1
|
26 kg/m^2
Interval 23.0 to 28.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 13 weeksKetone events defined as day with ketone level \> 1.0 mmol/L
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=54 Participants
Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).
|
Predictive-Low Glucose Suspend (PLGS)
n=55 Participants
Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will use CLC through commercial availability of the device after the 3 months extension (Objective 3 of the trial).
|
SAP to CLC Group
n=55 Participants
Participants in this arm were transitioned to CLC (t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM) after the extension began. Participants in this arm had previously been randomized to Sensor-Augmented Pump (SAP) in the primary trial (DCLP3 Pivotal Trial). This arm met Objective 2 of the study and was not compared to the CLC and PLGS groups that were randomized during the extension.
Participants in this arm will continue to use CLC through commercial availability of the device after the completion of the 3 months extension (Objective 3 of the trial).
|
|---|---|---|---|
|
Ketone Events Defined as Day With Ketone Level >1.0 mmol/L
|
5 Participants
|
1 Participants
|
7 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 13 weeksCGM-measured hypoglycemic events (\>15 minutes with glucose concentration \<54 mg/dL).
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=54 Participants
Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).
|
Predictive-Low Glucose Suspend (PLGS)
n=55 Participants
Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will use CLC through commercial availability of the device after the 3 months extension (Objective 3 of the trial).
|
SAP to CLC Group
n=55 Participants
Participants in this arm were transitioned to CLC (t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM) after the extension began. Participants in this arm had previously been randomized to Sensor-Augmented Pump (SAP) in the primary trial (DCLP3 Pivotal Trial). This arm met Objective 2 of the study and was not compared to the CLC and PLGS groups that were randomized during the extension.
Participants in this arm will continue to use CLC through commercial availability of the device after the completion of the 3 months extension (Objective 3 of the trial).
|
|---|---|---|---|
|
CGM-measured Hypoglycemic Events (>15 Minutes With Glucose Concentration <54 mg/dL)
|
0.4 event rate per week
Interval 0.1 to 0.9
|
0.5 event rate per week
Interval 0.1 to 0.9
|
0.4 event rate per week
Interval 0.2 to 0.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 13 weeksCGM-measured hyperglycemic events (\>15 minutes with glucose concentration \>300 mg/dL).
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=54 Participants
Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).
|
Predictive-Low Glucose Suspend (PLGS)
n=55 Participants
Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will use CLC through commercial availability of the device after the 3 months extension (Objective 3 of the trial).
|
SAP to CLC Group
n=55 Participants
Participants in this arm were transitioned to CLC (t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM) after the extension began. Participants in this arm had previously been randomized to Sensor-Augmented Pump (SAP) in the primary trial (DCLP3 Pivotal Trial). This arm met Objective 2 of the study and was not compared to the CLC and PLGS groups that were randomized during the extension.
Participants in this arm will continue to use CLC through commercial availability of the device after the completion of the 3 months extension (Objective 3 of the trial).
|
|---|---|---|---|
|
CGM-measured Hyperglycemic Events (>15 Minutes With Glucose Concentration >300 mg/dL)
|
1.6 Event Rate per Week
Interval 0.5 to 3.1
|
2.3 Event Rate per Week
Interval 0.9 to 5.3
|
1.0 Event Rate per Week
Interval 0.6 to 3.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 13 weeksWorsening of HbA1c from randomization to 13 weeks by \>0.5%.
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=54 Participants
Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).
|
Predictive-Low Glucose Suspend (PLGS)
n=55 Participants
Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will use CLC through commercial availability of the device after the 3 months extension (Objective 3 of the trial).
|
SAP to CLC Group
n=55 Participants
Participants in this arm were transitioned to CLC (t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM) after the extension began. Participants in this arm had previously been randomized to Sensor-Augmented Pump (SAP) in the primary trial (DCLP3 Pivotal Trial). This arm met Objective 2 of the study and was not compared to the CLC and PLGS groups that were randomized during the extension.
Participants in this arm will continue to use CLC through commercial availability of the device after the completion of the 3 months extension (Objective 3 of the trial).
|
|---|---|---|---|
|
Worsening of HbA1c From Randomization to 13 Weeks by >0.5%
|
8 Participants
|
20 Participants
|
3 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 13 weeksSerious adverse events with a possible or greater relationship to a study device (including anticipated and unanticipated adverse device effects).
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=54 Participants
Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).
|
Predictive-Low Glucose Suspend (PLGS)
n=55 Participants
Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will use CLC through commercial availability of the device after the 3 months extension (Objective 3 of the trial).
|
SAP to CLC Group
n=55 Participants
Participants in this arm were transitioned to CLC (t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM) after the extension began. Participants in this arm had previously been randomized to Sensor-Augmented Pump (SAP) in the primary trial (DCLP3 Pivotal Trial). This arm met Objective 2 of the study and was not compared to the CLC and PLGS groups that were randomized during the extension.
Participants in this arm will continue to use CLC through commercial availability of the device after the completion of the 3 months extension (Objective 3 of the trial).
|
|---|---|---|---|
|
Serious Adverse Events With a Possible or Greater Relationship to a Study Device (Including Anticipated and Unanticipated Adverse Device Effects)
|
0 Events
|
0 Events
|
0 Events
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 13 weeksAdverse device effects (ADE) that do not meet criteria for SAE.
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=54 Participants
Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).
|
Predictive-Low Glucose Suspend (PLGS)
n=55 Participants
Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will use CLC through commercial availability of the device after the 3 months extension (Objective 3 of the trial).
|
SAP to CLC Group
n=55 Participants
Participants in this arm were transitioned to CLC (t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM) after the extension began. Participants in this arm had previously been randomized to Sensor-Augmented Pump (SAP) in the primary trial (DCLP3 Pivotal Trial). This arm met Objective 2 of the study and was not compared to the CLC and PLGS groups that were randomized during the extension.
Participants in this arm will continue to use CLC through commercial availability of the device after the completion of the 3 months extension (Objective 3 of the trial).
|
|---|---|---|---|
|
Adverse Device Effects (ADE) That do Not Meet Criteria for SAE
|
0 Events
|
0 Events
|
0 Events
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 13 weeksOther serious adverse events not related to a study device.
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=54 Participants
Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).
|
Predictive-Low Glucose Suspend (PLGS)
n=55 Participants
Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will use CLC through commercial availability of the device after the 3 months extension (Objective 3 of the trial).
|
SAP to CLC Group
n=55 Participants
Participants in this arm were transitioned to CLC (t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM) after the extension began. Participants in this arm had previously been randomized to Sensor-Augmented Pump (SAP) in the primary trial (DCLP3 Pivotal Trial). This arm met Objective 2 of the study and was not compared to the CLC and PLGS groups that were randomized during the extension.
Participants in this arm will continue to use CLC through commercial availability of the device after the completion of the 3 months extension (Objective 3 of the trial).
|
|---|---|---|---|
|
Other Serious Adverse Events Not Related to a Study Device
|
0 Events
|
0 Events
|
0 Events
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 13 weeksNumber of Severe Hypoglycemic events over initial 13 weeks of trial
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=54 Participants
Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).
|
Predictive-Low Glucose Suspend (PLGS)
n=55 Participants
Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will use CLC through commercial availability of the device after the 3 months extension (Objective 3 of the trial).
|
SAP to CLC Group
n=55 Participants
Participants in this arm were transitioned to CLC (t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM) after the extension began. Participants in this arm had previously been randomized to Sensor-Augmented Pump (SAP) in the primary trial (DCLP3 Pivotal Trial). This arm met Objective 2 of the study and was not compared to the CLC and PLGS groups that were randomized during the extension.
Participants in this arm will continue to use CLC through commercial availability of the device after the completion of the 3 months extension (Objective 3 of the trial).
|
|---|---|---|---|
|
Severe Hypoglycemic Events
|
0 Events
|
0 Events
|
0 Events
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 13 weeksNumber of severe hypoglycemic events per 100 person-years over initial 13 weeks of trial
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=54 Participants
Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).
|
Predictive-Low Glucose Suspend (PLGS)
n=55 Participants
Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will use CLC through commercial availability of the device after the 3 months extension (Objective 3 of the trial).
|
SAP to CLC Group
n=55 Participants
Participants in this arm were transitioned to CLC (t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM) after the extension began. Participants in this arm had previously been randomized to Sensor-Augmented Pump (SAP) in the primary trial (DCLP3 Pivotal Trial). This arm met Objective 2 of the study and was not compared to the CLC and PLGS groups that were randomized during the extension.
Participants in this arm will continue to use CLC through commercial availability of the device after the completion of the 3 months extension (Objective 3 of the trial).
|
|---|---|---|---|
|
Severe Hypoglycemic Event Rate Per 100 Person-years
|
0 Events per 100 person-years
|
0 Events per 100 person-years
|
0 Events per 100 person-years
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 13 weeksNumber of DKA events over initial 13 weeks of trial
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=54 Participants
Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).
|
Predictive-Low Glucose Suspend (PLGS)
n=55 Participants
Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will use CLC through commercial availability of the device after the 3 months extension (Objective 3 of the trial).
|
SAP to CLC Group
n=55 Participants
Participants in this arm were transitioned to CLC (t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM) after the extension began. Participants in this arm had previously been randomized to Sensor-Augmented Pump (SAP) in the primary trial (DCLP3 Pivotal Trial). This arm met Objective 2 of the study and was not compared to the CLC and PLGS groups that were randomized during the extension.
Participants in this arm will continue to use CLC through commercial availability of the device after the completion of the 3 months extension (Objective 3 of the trial).
|
|---|---|---|---|
|
Diabetic Ketoacidosis (DKA) Events
|
0 Events
|
0 Events
|
0 Events
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 13 weeksNumber of DKA events per 100 person-years over initial 13 weeks
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=54 Participants
Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).
|
Predictive-Low Glucose Suspend (PLGS)
n=55 Participants
Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will use CLC through commercial availability of the device after the 3 months extension (Objective 3 of the trial).
|
SAP to CLC Group
n=55 Participants
Participants in this arm were transitioned to CLC (t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM) after the extension began. Participants in this arm had previously been randomized to Sensor-Augmented Pump (SAP) in the primary trial (DCLP3 Pivotal Trial). This arm met Objective 2 of the study and was not compared to the CLC and PLGS groups that were randomized during the extension.
Participants in this arm will continue to use CLC through commercial availability of the device after the completion of the 3 months extension (Objective 3 of the trial).
|
|---|---|---|---|
|
Diabetic Ketoacidosis (DKA) Event Rate Per 100 Person-years
|
0 Events per 100 person-years
|
0 Events per 100 person-years
|
0 Events per 100 person-years
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 13 weeksNumber of adverse events per 100 person-years over initial 13 weeks
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=54 Participants
Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).
|
Predictive-Low Glucose Suspend (PLGS)
n=55 Participants
Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will use CLC through commercial availability of the device after the 3 months extension (Objective 3 of the trial).
|
SAP to CLC Group
n=55 Participants
Participants in this arm were transitioned to CLC (t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM) after the extension began. Participants in this arm had previously been randomized to Sensor-Augmented Pump (SAP) in the primary trial (DCLP3 Pivotal Trial). This arm met Objective 2 of the study and was not compared to the CLC and PLGS groups that were randomized during the extension.
Participants in this arm will continue to use CLC through commercial availability of the device after the completion of the 3 months extension (Objective 3 of the trial).
|
|---|---|---|---|
|
Any Adverse Event Rate Per 100 Person-years
|
0 Events per 100 person-years
|
22.2 Events per 100 person-years
|
14.6 Events per 100 person-years
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Months 4-12CGM time in target range 70-180mg/dL for all participants using CLC from Months 4-12.
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=161 Participants
Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).
|
Predictive-Low Glucose Suspend (PLGS)
Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will use CLC through commercial availability of the device after the 3 months extension (Objective 3 of the trial).
|
SAP to CLC Group
Participants in this arm were transitioned to CLC (t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM) after the extension began. Participants in this arm had previously been randomized to Sensor-Augmented Pump (SAP) in the primary trial (DCLP3 Pivotal Trial). This arm met Objective 2 of the study and was not compared to the CLC and PLGS groups that were randomized during the extension.
Participants in this arm will continue to use CLC through commercial availability of the device after the completion of the 3 months extension (Objective 3 of the trial).
|
|---|---|---|---|
|
Time in Target Range From Months 4-12
|
68.8 percentage time in range
Standard Deviation 12.4
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Months 4-12CGM-measured % above 180mg/dL from Months 4-12
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=161 Participants
Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).
|
Predictive-Low Glucose Suspend (PLGS)
Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will use CLC through commercial availability of the device after the 3 months extension (Objective 3 of the trial).
|
SAP to CLC Group
Participants in this arm were transitioned to CLC (t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM) after the extension began. Participants in this arm had previously been randomized to Sensor-Augmented Pump (SAP) in the primary trial (DCLP3 Pivotal Trial). This arm met Objective 2 of the study and was not compared to the CLC and PLGS groups that were randomized during the extension.
Participants in this arm will continue to use CLC through commercial availability of the device after the completion of the 3 months extension (Objective 3 of the trial).
|
|---|---|---|---|
|
CGM Time Above 180 From Months 4-12
|
30 percentage of time
Standard Deviation 13
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Months 4-12CGM-measured mean glucose from Months 4-12
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=161 Participants
Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).
|
Predictive-Low Glucose Suspend (PLGS)
Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will use CLC through commercial availability of the device after the 3 months extension (Objective 3 of the trial).
|
SAP to CLC Group
Participants in this arm were transitioned to CLC (t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM) after the extension began. Participants in this arm had previously been randomized to Sensor-Augmented Pump (SAP) in the primary trial (DCLP3 Pivotal Trial). This arm met Objective 2 of the study and was not compared to the CLC and PLGS groups that were randomized during the extension.
Participants in this arm will continue to use CLC through commercial availability of the device after the completion of the 3 months extension (Objective 3 of the trial).
|
|---|---|---|---|
|
CGM Mean Glucose From Months 4-12
|
161 mg/dL
Standard Deviation 21
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Months 4-12CGM-measured % below 70 mg/dL from Months 4-12
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=161 Participants
Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).
|
Predictive-Low Glucose Suspend (PLGS)
Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will use CLC through commercial availability of the device after the 3 months extension (Objective 3 of the trial).
|
SAP to CLC Group
Participants in this arm were transitioned to CLC (t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM) after the extension began. Participants in this arm had previously been randomized to Sensor-Augmented Pump (SAP) in the primary trial (DCLP3 Pivotal Trial). This arm met Objective 2 of the study and was not compared to the CLC and PLGS groups that were randomized during the extension.
Participants in this arm will continue to use CLC through commercial availability of the device after the completion of the 3 months extension (Objective 3 of the trial).
|
|---|---|---|---|
|
CGM Time Below 70 From Months 4-12
|
1.38 percentage of time
Standard Deviation 0.98
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Months 4-12CGM-measured % time below 54mg/dL from Months 4-12
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=161 Participants
Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).
|
Predictive-Low Glucose Suspend (PLGS)
Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will use CLC through commercial availability of the device after the 3 months extension (Objective 3 of the trial).
|
SAP to CLC Group
Participants in this arm were transitioned to CLC (t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM) after the extension began. Participants in this arm had previously been randomized to Sensor-Augmented Pump (SAP) in the primary trial (DCLP3 Pivotal Trial). This arm met Objective 2 of the study and was not compared to the CLC and PLGS groups that were randomized during the extension.
Participants in this arm will continue to use CLC through commercial availability of the device after the completion of the 3 months extension (Objective 3 of the trial).
|
|---|---|---|---|
|
CGM Time Below 54 From Months 4-12
|
0.17 percentage of time
Interval 0.08 to 0.35
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Months 4-12CGM-measured % time in range 70-140mg/dL from Months 4-12
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=161 Participants
Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).
|
Predictive-Low Glucose Suspend (PLGS)
Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will use CLC through commercial availability of the device after the 3 months extension (Objective 3 of the trial).
|
SAP to CLC Group
Participants in this arm were transitioned to CLC (t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM) after the extension began. Participants in this arm had previously been randomized to Sensor-Augmented Pump (SAP) in the primary trial (DCLP3 Pivotal Trial). This arm met Objective 2 of the study and was not compared to the CLC and PLGS groups that were randomized during the extension.
Participants in this arm will continue to use CLC through commercial availability of the device after the completion of the 3 months extension (Objective 3 of the trial).
|
|---|---|---|---|
|
CGM Time in Range 70-140 mg/dL From Months 4-12
|
43.6 percentage of time
Standard Deviation 11.4
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Months 4-12CGM measured glucose variability measured with the coefficient of variation from Months 4-12
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=161 Participants
Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).
|
Predictive-Low Glucose Suspend (PLGS)
Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will use CLC through commercial availability of the device after the 3 months extension (Objective 3 of the trial).
|
SAP to CLC Group
Participants in this arm were transitioned to CLC (t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM) after the extension began. Participants in this arm had previously been randomized to Sensor-Augmented Pump (SAP) in the primary trial (DCLP3 Pivotal Trial). This arm met Objective 2 of the study and was not compared to the CLC and PLGS groups that were randomized during the extension.
Participants in this arm will continue to use CLC through commercial availability of the device after the completion of the 3 months extension (Objective 3 of the trial).
|
|---|---|---|---|
|
Coefficient of Variation From Months 4-12
|
34 percentage SD of mean
Standard Deviation 5
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Months 4-12CGM measured glucose variability measured with the standard deviation (SD) from Months 4-12
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=161 Participants
Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).
|
Predictive-Low Glucose Suspend (PLGS)
Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will use CLC through commercial availability of the device after the 3 months extension (Objective 3 of the trial).
|
SAP to CLC Group
Participants in this arm were transitioned to CLC (t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM) after the extension began. Participants in this arm had previously been randomized to Sensor-Augmented Pump (SAP) in the primary trial (DCLP3 Pivotal Trial). This arm met Objective 2 of the study and was not compared to the CLC and PLGS groups that were randomized during the extension.
Participants in this arm will continue to use CLC through commercial availability of the device after the completion of the 3 months extension (Objective 3 of the trial).
|
|---|---|---|---|
|
Standard Deviation From Months 4-12
|
56 mg/dL
Standard Deviation 14
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Months 4-12CGM-measured % below 60mg/dL from Months 4-12
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=161 Participants
Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).
|
Predictive-Low Glucose Suspend (PLGS)
Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will use CLC through commercial availability of the device after the 3 months extension (Objective 3 of the trial).
|
SAP to CLC Group
Participants in this arm were transitioned to CLC (t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM) after the extension began. Participants in this arm had previously been randomized to Sensor-Augmented Pump (SAP) in the primary trial (DCLP3 Pivotal Trial). This arm met Objective 2 of the study and was not compared to the CLC and PLGS groups that were randomized during the extension.
Participants in this arm will continue to use CLC through commercial availability of the device after the completion of the 3 months extension (Objective 3 of the trial).
|
|---|---|---|---|
|
CGM Time Below 60 From Months 4-12
|
0.37 percentage of time
Interval 0.17 to 0.7
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Months 4-12LBGI from Months 4-12. Low blood glucose index by CGM with higher index indicating higher risk of hypoglycemia. Values \<1 suggest minimal risk. Index of risk of low blood glucose excursion based on a standard formula for non-linear transformation of the blood glucose scale (Kovatchev BP, Cox DJ, Gonder-Frederick LA, Young-Hyman D, Schlundt D, Clarke WL: Assessment of risk for severe hypoglycemia among adults with IDDM: validation of the low blood glucose index. Diabetes Care 21:1870-1875, 1998)
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=161 Participants
Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).
|
Predictive-Low Glucose Suspend (PLGS)
Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will use CLC through commercial availability of the device after the 3 months extension (Objective 3 of the trial).
|
SAP to CLC Group
Participants in this arm were transitioned to CLC (t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM) after the extension began. Participants in this arm had previously been randomized to Sensor-Augmented Pump (SAP) in the primary trial (DCLP3 Pivotal Trial). This arm met Objective 2 of the study and was not compared to the CLC and PLGS groups that were randomized during the extension.
Participants in this arm will continue to use CLC through commercial availability of the device after the completion of the 3 months extension (Objective 3 of the trial).
|
|---|---|---|---|
|
LBGI From Months 4-12
|
0.45 index
Standard Deviation 0.25
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Months 4-12HBGI from Months 4-12. High blood glucose index by CGM with higher values indicating higher risk of hyperglycemia. Index of risk of high blood glucose excursion based on a standard formula for non-linear transformation of the blood glucose scale (Kovatchev BP, Cox DJ, Kumar A, Gonder-Frederick L, Clarke WL. Algorithmic evaluation of metabolic control and risk of severe hypoglycemia in type 1 and type 2 diabetes using self-monitoring blood glucose data. Diabetes Technol Ther 2003;5:817-828pmid:14633347)
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=161 Participants
Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).
|
Predictive-Low Glucose Suspend (PLGS)
Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will use CLC through commercial availability of the device after the 3 months extension (Objective 3 of the trial).
|
SAP to CLC Group
Participants in this arm were transitioned to CLC (t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM) after the extension began. Participants in this arm had previously been randomized to Sensor-Augmented Pump (SAP) in the primary trial (DCLP3 Pivotal Trial). This arm met Objective 2 of the study and was not compared to the CLC and PLGS groups that were randomized during the extension.
Participants in this arm will continue to use CLC through commercial availability of the device after the completion of the 3 months extension (Objective 3 of the trial).
|
|---|---|---|---|
|
HBGI From Months 4-12
|
7.1 index
Standard Deviation 3.8
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Months 4-12CGM-measured events of at least 15 consecutive minutes \<70mg/dL from Months 4-12
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=161 Participants
Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).
|
Predictive-Low Glucose Suspend (PLGS)
Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will use CLC through commercial availability of the device after the 3 months extension (Objective 3 of the trial).
|
SAP to CLC Group
Participants in this arm were transitioned to CLC (t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM) after the extension began. Participants in this arm had previously been randomized to Sensor-Augmented Pump (SAP) in the primary trial (DCLP3 Pivotal Trial). This arm met Objective 2 of the study and was not compared to the CLC and PLGS groups that were randomized during the extension.
Participants in this arm will continue to use CLC through commercial availability of the device after the completion of the 3 months extension (Objective 3 of the trial).
|
|---|---|---|---|
|
CGM Hypoglycemia Events From Months 4-12
|
2.9 Events per Week
Standard Deviation 1.9
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Months 4-12CGM-measured % time \>250 mg/dL from Months 4-12
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=161 Participants
Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).
|
Predictive-Low Glucose Suspend (PLGS)
Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will use CLC through commercial availability of the device after the 3 months extension (Objective 3 of the trial).
|
SAP to CLC Group
Participants in this arm were transitioned to CLC (t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM) after the extension began. Participants in this arm had previously been randomized to Sensor-Augmented Pump (SAP) in the primary trial (DCLP3 Pivotal Trial). This arm met Objective 2 of the study and was not compared to the CLC and PLGS groups that were randomized during the extension.
Participants in this arm will continue to use CLC through commercial availability of the device after the completion of the 3 months extension (Objective 3 of the trial).
|
|---|---|---|---|
|
CGM Time >250 From Months 4-12
|
8.9 percentage of time
Standard Deviation 8.4
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Months 4-12CGM-measured % time \>300 mg/dL from Months 4-12
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=161 Participants
Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).
|
Predictive-Low Glucose Suspend (PLGS)
Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will use CLC through commercial availability of the device after the 3 months extension (Objective 3 of the trial).
|
SAP to CLC Group
Participants in this arm were transitioned to CLC (t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM) after the extension began. Participants in this arm had previously been randomized to Sensor-Augmented Pump (SAP) in the primary trial (DCLP3 Pivotal Trial). This arm met Objective 2 of the study and was not compared to the CLC and PLGS groups that were randomized during the extension.
Participants in this arm will continue to use CLC through commercial availability of the device after the completion of the 3 months extension (Objective 3 of the trial).
|
|---|---|---|---|
|
CGM Time >300 From Months 4-12
|
3.5 percentage of time
Standard Deviation 5.0
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Month 6 of studyHbA1c measured at Month 6 of this extension study
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=160 Participants
Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).
|
Predictive-Low Glucose Suspend (PLGS)
Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will use CLC through commercial availability of the device after the 3 months extension (Objective 3 of the trial).
|
SAP to CLC Group
Participants in this arm were transitioned to CLC (t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM) after the extension began. Participants in this arm had previously been randomized to Sensor-Augmented Pump (SAP) in the primary trial (DCLP3 Pivotal Trial). This arm met Objective 2 of the study and was not compared to the CLC and PLGS groups that were randomized during the extension.
Participants in this arm will continue to use CLC through commercial availability of the device after the completion of the 3 months extension (Objective 3 of the trial).
|
|---|---|---|---|
|
HbA1c at Month 6
|
7.04 % of glycated hemoglobin
Standard Deviation 0.76
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Month 9 of studyHbA1c measured at month 9 of this extension study
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=157 Participants
Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).
|
Predictive-Low Glucose Suspend (PLGS)
Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will use CLC through commercial availability of the device after the 3 months extension (Objective 3 of the trial).
|
SAP to CLC Group
Participants in this arm were transitioned to CLC (t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM) after the extension began. Participants in this arm had previously been randomized to Sensor-Augmented Pump (SAP) in the primary trial (DCLP3 Pivotal Trial). This arm met Objective 2 of the study and was not compared to the CLC and PLGS groups that were randomized during the extension.
Participants in this arm will continue to use CLC through commercial availability of the device after the completion of the 3 months extension (Objective 3 of the trial).
|
|---|---|---|---|
|
HbA1c at Month 9
|
6.95 % of glycated hemoglobin
Standard Deviation 0.8
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Month 12 of studyHbA1c measured at Month 12 of this extension study
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=102 Participants
Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).
|
Predictive-Low Glucose Suspend (PLGS)
Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will use CLC through commercial availability of the device after the 3 months extension (Objective 3 of the trial).
|
SAP to CLC Group
Participants in this arm were transitioned to CLC (t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM) after the extension began. Participants in this arm had previously been randomized to Sensor-Augmented Pump (SAP) in the primary trial (DCLP3 Pivotal Trial). This arm met Objective 2 of the study and was not compared to the CLC and PLGS groups that were randomized during the extension.
Participants in this arm will continue to use CLC through commercial availability of the device after the completion of the 3 months extension (Objective 3 of the trial).
|
|---|---|---|---|
|
HbA1c at Month 12
|
6.92 % of glycated hemoglobin
Standard Deviation 0.74
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Months 4-12Ketone Events Defined as Number of Days with at least one Ketone Level \>1.0 mmol/L from Months 4-12
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=161 Participants
Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).
|
Predictive-Low Glucose Suspend (PLGS)
Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will use CLC through commercial availability of the device after the 3 months extension (Objective 3 of the trial).
|
SAP to CLC Group
Participants in this arm were transitioned to CLC (t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM) after the extension began. Participants in this arm had previously been randomized to Sensor-Augmented Pump (SAP) in the primary trial (DCLP3 Pivotal Trial). This arm met Objective 2 of the study and was not compared to the CLC and PLGS groups that were randomized during the extension.
Participants in this arm will continue to use CLC through commercial availability of the device after the completion of the 3 months extension (Objective 3 of the trial).
|
|---|---|---|---|
|
Ketone Events Defined as Days With Ketone Level >1.0 mmol/L From Months 4-12
|
38 days
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Months 4-12CGM-measured Hypoglycemia Events (\>15 minutes with glucose concentration \<54mg/dL) from Months 4-12 measured as a rate per week.
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=161 Participants
Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).
|
Predictive-Low Glucose Suspend (PLGS)
Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will use CLC through commercial availability of the device after the 3 months extension (Objective 3 of the trial).
|
SAP to CLC Group
Participants in this arm were transitioned to CLC (t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM) after the extension began. Participants in this arm had previously been randomized to Sensor-Augmented Pump (SAP) in the primary trial (DCLP3 Pivotal Trial). This arm met Objective 2 of the study and was not compared to the CLC and PLGS groups that were randomized during the extension.
Participants in this arm will continue to use CLC through commercial availability of the device after the completion of the 3 months extension (Objective 3 of the trial).
|
|---|---|---|---|
|
CGM-measured Hypoglycemia Events (>15 Minutes With Glucose Concentration <54mg/dL) From Months 4-12
|
0.3 Events per Week
Interval 0.1 to 0.7
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Months 4-12CGM-measured Hyperglycemic Events (\>15 consecutive minutes with CGM glucose \>300mg/dL) from Months 4-12
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=161 Participants
Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).
|
Predictive-Low Glucose Suspend (PLGS)
Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will use CLC through commercial availability of the device after the 3 months extension (Objective 3 of the trial).
|
SAP to CLC Group
Participants in this arm were transitioned to CLC (t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM) after the extension began. Participants in this arm had previously been randomized to Sensor-Augmented Pump (SAP) in the primary trial (DCLP3 Pivotal Trial). This arm met Objective 2 of the study and was not compared to the CLC and PLGS groups that were randomized during the extension.
Participants in this arm will continue to use CLC through commercial availability of the device after the completion of the 3 months extension (Objective 3 of the trial).
|
|---|---|---|---|
|
CGM-measured Hyperglycemic Events From Months 4-12
|
1.5 Event rate per week
Interval 0.8 to 4.0
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Months 4-12Number of Severe Hypoglycemic Events from Months 4-12.
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=161 Participants
Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).
|
Predictive-Low Glucose Suspend (PLGS)
Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will use CLC through commercial availability of the device after the 3 months extension (Objective 3 of the trial).
|
SAP to CLC Group
Participants in this arm were transitioned to CLC (t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM) after the extension began. Participants in this arm had previously been randomized to Sensor-Augmented Pump (SAP) in the primary trial (DCLP3 Pivotal Trial). This arm met Objective 2 of the study and was not compared to the CLC and PLGS groups that were randomized during the extension.
Participants in this arm will continue to use CLC through commercial availability of the device after the completion of the 3 months extension (Objective 3 of the trial).
|
|---|---|---|---|
|
Number of Severe Hypoglycemic Events From Months 4-12
|
4 events
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Months 4-12Number of Diabetic Ketoacidosis (DKA) events from Months 4-12.
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=161 Participants
Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).
|
Predictive-Low Glucose Suspend (PLGS)
Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will use CLC through commercial availability of the device after the 3 months extension (Objective 3 of the trial).
|
SAP to CLC Group
Participants in this arm were transitioned to CLC (t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM) after the extension began. Participants in this arm had previously been randomized to Sensor-Augmented Pump (SAP) in the primary trial (DCLP3 Pivotal Trial). This arm met Objective 2 of the study and was not compared to the CLC and PLGS groups that were randomized during the extension.
Participants in this arm will continue to use CLC through commercial availability of the device after the completion of the 3 months extension (Objective 3 of the trial).
|
|---|---|---|---|
|
Number of Diabetic Ketoacidosis (DKA) Events From Months 4-12
|
3 events
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Months 4-12Other Serious Adverse Events Not Related to a Study Device from Months 4-12.
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=161 Participants
Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).
|
Predictive-Low Glucose Suspend (PLGS)
Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will use CLC through commercial availability of the device after the 3 months extension (Objective 3 of the trial).
|
SAP to CLC Group
Participants in this arm were transitioned to CLC (t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM) after the extension began. Participants in this arm had previously been randomized to Sensor-Augmented Pump (SAP) in the primary trial (DCLP3 Pivotal Trial). This arm met Objective 2 of the study and was not compared to the CLC and PLGS groups that were randomized during the extension.
Participants in this arm will continue to use CLC through commercial availability of the device after the completion of the 3 months extension (Objective 3 of the trial).
|
|---|---|---|---|
|
Other Serious Adverse Events Not Related to a Study Device From Months 4-12
|
4 events
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Months 4-12Any Adverse Event Rate per 100 person-years from Months 4-12.
Outcome measures
| Measure |
Closed Loop Control (CLC)
n=161 Participants
Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).
|
Predictive-Low Glucose Suspend (PLGS)
Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will use CLC through commercial availability of the device after the 3 months extension (Objective 3 of the trial).
|
SAP to CLC Group
Participants in this arm were transitioned to CLC (t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM) after the extension began. Participants in this arm had previously been randomized to Sensor-Augmented Pump (SAP) in the primary trial (DCLP3 Pivotal Trial). This arm met Objective 2 of the study and was not compared to the CLC and PLGS groups that were randomized during the extension.
Participants in this arm will continue to use CLC through commercial availability of the device after the completion of the 3 months extension (Objective 3 of the trial).
|
|---|---|---|---|
|
Any Adverse Event Rate Per 100 Person-years From Months 4-12
|
39 events rate per 100 person-years
|
—
|
—
|
Adverse Events
Closed Loop Control (CLC)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Predictive-Low Glucose Suspend (PLGS)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
SAP to CLC Group
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Closed Loop Control (CLC)
n=54 participants at risk
Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).
|
Predictive-Low Glucose Suspend (PLGS)
n=55 participants at risk
Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ \& Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will use CLC through commercial availability of the device after the 3 months extension (Objective 3 of the trial).
|
SAP to CLC Group
n=55 participants at risk
Participants in this arm were transitioned to CLC (t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM) after the extension began. Participants in this arm had previously been randomized to Sensor-Augmented Pump (SAP) in the primary trial (DCLP3 Pivotal Trial). This arm met Objective 2 of the study and was not compared to the CLC and PLGS groups that were randomized during the extension.
Participants in this arm will continue to use CLC through commercial availability of the device after the completion of the 3 months extension (Objective 3 of the trial).
|
|---|---|---|---|
|
Endocrine disorders
Hyperglycemia or ketosis events without meeting criteria for Diabetic Ketoacidosis
|
0.00%
0/54 • 3 months
|
5.5%
3/55 • Number of events 3 • 3 months
|
3.6%
2/55 • Number of events 2 • 3 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place